Data Management (DM) and Biostatistics Core (Core B) will be developed for this ICEMR to support research activities of all projects, providing a centralized DM and analysis system that will be used by all the Consortium members. The primary goal of Core B activities will be to ensure data security, confidentiality and quality as well as provide stafistical support and facilitate communication among the specific project teams. These services represent a valuable integrative feature ofthis ICEMR program intended to meet the diverse needs of each project. We anticipate that this core will be beneficial and essential to the functioning and Integrafion of the various components of this program. Core B involves interdisciplinary scientific teams with key invesfigators from Guatemala, Panama, Colombia, Peru, the initial participating countries, and collaborators from Ecuador, Brazil, US and Europe. Close collaboration is expected to occur among all participants for the development of this DM system that will include data entry, checking and audit trials, tracking systems, security features, and personnel training. Data quality control will be provided by comparing report formats with data sources, assessing data for invalid or missing values, assuring that the data are in their intended operafionalized format, and assessing for deviance in general data patterns. In addifion this Core will give basis forthe implementation of data sharing policies. A Website will be developed for Core B that will have data upload and download capabilifies. This technological capability will facilitate high-level networking with our partner institutions. Statisfical support will be an integral component of this Core that will have biostatisficians as key members. As the studies planned for this ICEMR are observational, epidemiological support will be a key issue for valid and efficient design of study protocols Those activifies will include advice in study design and planning data analyses trying to minimize selection and information biases, for control of confounding factors, and to estimate sample sizes required for the testing of each hypothesis. Also as hierarchical levels of observation are proposed, database structure will be constructed accordingly. The Core will be directed by Dr Oscar Ramirez (MD/MPhll Epidemiology) with the support of a group of epidemiologists participafing in the specific projects (1-3), statisticians and support staff. Drs, G. Carrasquilla, J. Mateus, R. Montoya, F.De la Hoz (Colombia), Llanos (Peru) and C. Guerra (Ecuador) are all epidemiologists with great experience in study design and DM. In addition Dr. O Gomez (US) will provide biostatistics advice. The close relationship of these DM-Core staff members provides a very academic and collaborative environment.
This Core B will provide support to the research activities of all Projects and Cores, providing a centralized data management and analysis system, stafisfical support, training capacifies and communicafion mechanisms to all the Consortium members.
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